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Pneumonectomy and Protective Mechanical Ventilation (VPP)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, December 2008
First Received: December 8, 2008   Last Updated: December 18, 2008   History of Changes
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00805077
  Purpose

The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy for lung cancer.


Condition Intervention
Lung Neoplasms
Procedure: mechanical ventilation
Other: tidal volume

MedlinePlus related topics: Cancer Lung Cancer Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Pneumonectomy and Protective Mechanical Ventilation

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Major postoperative complications during the first 30 days after surgery [ Time Frame: the first 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death [ Time Frame: during the first 30 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
Procedure: mechanical ventilation
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
2
tidal volume of 10 ml/kg of ideal body weight without PEEP
Other: tidal volume
tidal volume of 10 ml/kg of ideal body weight without PEEP

Detailed Description:

Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE HOSPITAL, University of Paris-VI and by principal investigator.

Pneumonectomy is associated with a high risk for postoperative complication. The benefit of lung protective ventilation with low tidal volume has been demonstrated in patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent clinical studies have suggested that mechanical ventilation with low tidal volume may also profit in others setting. Lung protective ventilation during anaesthesia has been found to limit the inflammatory response in the lung and to decrease postoperative systemic inflammatory response. However, others trials did not found benefit of protective ventilation strategy during anaesthesia. This study will be a randomized, controlled, doubled blind trial comparing two management ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing pneumonectomy for lung primitive cancer will be included in this trial. During anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis, complications, cancer recurrence and death will be collected.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary lung cancer.
  • Elective Pneumonectomy
  • Written informed consent

Exclusion Criteria:

  • Patients undergoing surgical procedure other than pneumonectomy
  • Mesothelioma
  • Liver cirrhosis
  • Chronic renal failure
  • Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive sleep apnea syndrome for example) before surgery
  • Emergency surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805077

Contacts
Contact: Emmanuel Marret, MD +33 (0) 1 56 01 65 72 emmanuel.marret@tnn.aphp.fr

Locations
France
Departement d'Anesthesie Reanimation, Hopital Tenon Recruiting
Paris, France, 75020
Contact: Emmanuel Marret, MD     33 (0) 1 56 01 65 72     emmanuel.marret@tnn.aphp.fr    
Principal Investigator: Emmanuel Marret, MD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Emmanuel Marret, MD Hopital Tenon, Assistance Publique - Hopitaux de Paris
  More Information

No publications provided

Responsible Party: Department Clinical Research of Developpement ( Mathieu Quintin )
Study ID Numbers: P070119, A00821-52
Study First Received: December 8, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00805077     History of Changes
Health Authority: France: Direction Générale de la Santé;   France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
interoperative care
Tidal volume
Postoperative complications
Pneumonectomy
Mechanical ventilation

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Postoperative Complications
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009